Status:
COMPLETED
Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Traumatic Brain Injury
Lead Sponsor:
Khon Kaen University
Collaborating Sponsors:
Thailand Research Fund
Khon Kaen Hospital
Conditions:
Brain Injuries
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The study's objective is to evaluate the effectiveness and safety of tranexamic acid for adult patients with moderate to severe TBI.With the research question as "Does TXA reduce the incidence of prog...
Detailed Description
Traumatic brain injury (TBI) is a major public health problem with poor outcome especially with progressive intracranial haemorrhage (PIH) in severe patients. There are links between coagulopathic cha...
Eligibility Criteria
Inclusion
- moderate to severe injuries(post-resuscitation scores GCS 4-12)
- age \>= 16 year
- non-penetrating TBI in 8 hours onset
- first CT brain in 8 hours onset
- non neurosurgical OR in 8 hours onset
Exclusion
- patients with coagulopathy
- serum creatinine over than 2 mg%
- with associated major organ injury requiring surgery within 8 hours of injury
- pregnancy
- receiving any medication which affects haemostasis
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT00755209
Start Date
October 1 2008
End Date
October 1 2009
Last Update
November 25 2013
Active Locations (1)
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1
Khon Kaen Regional hospital
Muang District, Changwat Khon Kaen, Thailand, 40000